FDA Registration
Active
🇩🇪 Germany
IntelliVue Patient Monitor XG50 - 866063
Reg #: 9610816
·
FEI: 3002807167
·
Expires 2025
Products
8
Proprietary Names
3
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Philips Medizin Systeme Boeblingen GmbH
- Registration Number
- 9610816
- FEI Number
- 3002807167
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HEWLETT-PACKARD STRASSE 2
- City
- BOEBLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K161531
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Deborah Currlin
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
- [email protected]
- Phone
- 858 9452753
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2016-07-13 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2016-07-13 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2016-07-13 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2016-07-13 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2016-07-13 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2016-07-13 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2016-07-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2016-07-13 |
Proprietary Names
IntelliVue Patient Monitor XG50 - 866063
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450
IntelliVue Patient Monitors MX450, MX500, MX550, MX600, MX700, MX800 and the Multi-Measurement Module X2
Establishment Types
Manufacture Medical Device